The present invention is directed to a system for containing and delivering a fluid. More particularly, the present invention is directed to a closure system that permits the introduction and withdrawal of fluid from a container using an instrument having a blunt, luer-type connector.
Many pharmaceutical products are delivered to pharmacies in sealed containers such as vials, glass or plastic bottles, and flexible bags. Such containers can contain a powdered or lyophilized formulation of a pharmaceutical product that must be reconstituted prior to administration to a patient. In addition, such containers can contain a solution formulation of a pharmaceutical product that can be withdrawn from the container and administered directly to a patient, for example, by parenteral administration.
Most pharmaceutical vials are fluidly sealed by a pierceable stopper, thereby isolating the contents of the vial from the vial""s external environment. In order to access the pharmaceutical product within the vial, it is necessary either to pierce the stopper or to remove the stopper from the vial. However, removal of the stopper results in exposure of the pharmaceutical product to the external environment of the vial, thereby compromising the sterility and/or stability of the pharmaceutical product within the vial. For this reason, it often is preferable to access the pharmaceutical product by piercing the stopper.
The piercing of vial stoppers typically has been achieved through the use of sharp, small-bored needles. Standard hypodermic needles are particularly useful for this purpose because they allow the pharmaceutical product to be aseptically withdrawn from the vial and parenterally administered directly to a patient using a single device, thereby minimizing the risk of contamination of the pharmaceutical product. However, hypodermic needles pose a risk of inadvertent needle sticks to medical professionals. Due to growing concerns regarding the possible transmission of HIV and other diseases through needle sticks, there has been a significant trend away from the use of hypodermic needles. In addition, in many cases it is necessary to clean the outer surface of the vial stopper prior to piercing in order to reduce the risk of infection to the patient. This requires the medical professional to perform two distinct steps in order to withdraw the pharmaceutical product from the vial.
Various systems have been developed in order to eliminate the use of hypodermic needles in reconstituting and/or withdrawing pharmaceutical products from vials. For example, U.S. Pat. No. 5,171,214 discloses a system having a cannula surrounded by a protective skirt assembly, thereby reducing the possibility of an inadvertent needle stick. Other systems employ pre-slit stoppers that can be pierced using blunt cannulas, thereby obviating the need for a hypodermic needle. Still other systems, such as that disclosed in U.S. Pat. No. 2,342,215, permit blunt needle access to the contents of a vial through the use of a piercing member disposed within a stopper, the piercing member being activated through the application of an inwardly directed force using the blunt needle.
The system of the present invention provides a closure system for a container. The system includes a stopper having a lower surface configured to seal fluidly a container. A closure member is mounted on an upper surface of the stopper. The closure member includes a base, a lower surface of which is configured to engage the upper surface of the stopper. The closure member further includes an inner wall and an outer wall extending from an upper surface of the base, the inner wall being spaced from the outer wall. A needle access port is defined through the base of the closure member at a position between the inner and outer walls. In addition, an aperture is defined through the base at a position adjacent to a chamber defined by the inner wall. The system further includes a piercing member that is movably disposed within the chamber defined by the inner wall. The piercing member has a first end portion and a second end portion. A piercing tip is mounted on the first end portion, the piercing tip being configured to pierce the stopper. The second end portion is configured to engage a luer inserted into the chamber defined by the inner wall. A channel is defined through the piercing member such that fluid can be moved therethrough.
In an alternative embodiment of the present invention, the closure system includes a stopper having a lower surface configured to seal fluidly a container. A closure member is mounted on an upper surface of the stopper. The closure member includes a base, a lower surface of which is configured to engage the upper surface of the stopper. The closure member further includes a wall extending from an upper surface of the base. The wall defines a chamber therein. An aperture is defined through the base at a position adjacent to the chamber defined by the wall. The system also includes a piercing member movably disposed within the chamber defined by the wall. The piercing member has a first end portion and a second end portion. A piercing tip is mounted on the first end portion, the piercing tip being configured to pierce the stopper. The second end portion of the piercing member is configured to engage a luer inserted into the chamber defined by the wall. A channel is defined through the piercing member such that fluid can be moved therethrough. The system further includes a sealing member fluidly sealing the chamber defined by the wall.